Cleared Traditional

AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT

K862300 · Amresco, Inc. · Chemistry
Jul 1986
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K862300 is an FDA 510(k) clearance for the AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT, a Flame Photometry, Potassium (Class II — Special Controls, product code JGM), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on July 29, 1986, 42 days after receiving the submission on June 17, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K862300 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1986
Decision Date July 29, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGM — Flame Photometry, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600